Development of a Response Signature to Neoadjuvant Chemotherapy for Breast Cancer (Breast-sign)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Genetic signature
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Women and men with breast cancer
- Treated with neoadjuvant chemotherapy
Exclusion Criteria:
- None
Sites / Locations
- Cliniques universitaires Saint-LucRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Retrospective study
Prospective study
Arm Description
Tumoral tissue of 100 patients with breast cancer treated with neoadjuvant chemotherapy.
Tumoral tissue and plasma of 120 patients with breast cancer treated with neoadjuvant chemotherapy.
Outcomes
Primary Outcome Measures
The number of molecular signatures predictive of response to neoadjuvant chemotherapy which would be able to discriminate between patient groups based on their epithelio-mesenchymal transition status and their immune status.
Secondary Outcome Measures
Full Information
NCT ID
NCT03314870
First Posted
September 23, 2017
Last Updated
July 12, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03314870
Brief Title
Development of a Response Signature to Neoadjuvant Chemotherapy for Breast Cancer
Acronym
Breast-sign
Official Title
Development of a Response Signature to Neoadjuvant Chemotherapy for Breast
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Breast cancer is the most frequent cancer in women. It is often treated with neoadjuvant chemotherapy, administered before surgical resection. Unfortunately, many patients do not respond to this treatment, or only respond partially. Clinicians therefore need predictive biomarkers of treatment response. Thanks to an innovative technique, called CATS, this study aims at identifying blood and tissue biomarkers which are predictive of response to chemotherapy.
Detailed Description
Breast cancer is the most frequent cancer in women. It is often treated with neoadjuvant chemotherapy, administered before surgical resection. Unfortunately, many patients do not respond to this treatment, or only respond partially. Clinicians therefore need predictive biomarkers of treatment response. Thanks to an innovative technique, called CATS, this study aims at identifying blood and tissue biomarkers which are predictive of response to chemotherapy.
The objective of this study is to develop molecular signatures predictive of response to neoadjuvant chemotherapy which would be able to discriminate between patient groups based on their epithelio-mesenchymal transition (EMT) status and their immune status. As these two parameters are known to be responsible for incomplete responses to chemotherapy, investigators hypothesize that these signatures will be predictive of response to neoadjuvant chemotherapy. In a second step, researchers will evaluate the ability of these signatures to predict treatment response in breast cancer patients treated with neoadjuvant chemotherapy.
The investigators will investigate two types of signatures: a tissue signature and a circulating signature. The former is based on the level of expression of several mRNA and miRNA assessed by CATS-RNASeq in the biopsy. The circulating signature will be based on the expression level of several miRNA by the same technique. Given that the expression level of tumoral miRNA is affected by the EMT and immunological status, and given that tumors secrete miRNA in the circulation, investigators expect the miRNA plasma content to reflect the EMT and immunological status of the tumor. The circulating signature will have the additional advantage of being independent of tumor heterogeneity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Retrospective study
Arm Type
Other
Arm Description
Tumoral tissue of 100 patients with breast cancer treated with neoadjuvant chemotherapy.
Arm Title
Prospective study
Arm Type
Other
Arm Description
Tumoral tissue and plasma of 120 patients with breast cancer treated with neoadjuvant chemotherapy.
Intervention Type
Genetic
Intervention Name(s)
Genetic signature
Intervention Description
To identify molecular signatures of EMT / immune status by using the random forest algorithm. The best signature will be measured by RT-qPCR and/or CATS-RNASeq technics.
Primary Outcome Measure Information:
Title
The number of molecular signatures predictive of response to neoadjuvant chemotherapy which would be able to discriminate between patient groups based on their epithelio-mesenchymal transition status and their immune status.
Time Frame
an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women and men with breast cancer
Treated with neoadjuvant chemotherapy
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François DUHOUX, MD, PhD
Phone
00 32 2 764
Email
francois.duhoux@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie BLONDEEL, MSc
Phone
00 32 2 764
Email
nathalie.blondeel@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François DUHOUX, MD, PhD
Organizational Affiliation
francois.duhoux@uclouvain.be
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François DUHOUX, MD,PhD
Phone
0032 2 764
Email
francois.duhoux@uclouvain.be
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no IPD
Learn more about this trial
Development of a Response Signature to Neoadjuvant Chemotherapy for Breast Cancer
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